Chronic rhinosinusitis MedDRA version: 19.1 Level: LLT Classification code 10052106 Term: Rhinosinusitis System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Sinupret extract
Product Name: Sinupret extract coated tablets
Pharmaceutical Form: Tablet
Other descriptive name: DRY EXTRACT (3-6:1) OF GENTIAN ROOT, PRIMULA FLOWERS, SORREL HERB, ELDER
Sponsors
Bionorica SE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent (IC) including data protection declaration 2. Male and female outpatients aged =18 and =75 years Women will be considered for inclusion if they are not pregnant (as confirmed by urine pregnancy test at V1 and V2), not breastfeeding, or if they are surgically sterile (have had a documented bilateral oophorectomy and/or hysterectomy) or if menopause is ensured (at least 12 months without menstrual bleeding). Women of childbearing potential must use a highly effective (failure rate less than 1% per year, i.e. Pearl Index 52 weeks prior to enrolment (V1) as documented in the medical file of the patient • Major Symptom Score (MSS) =10 at V1 and V2 as assessed by the investigator (MSSINV), and rhinorrhea (anterior or posterior) and pain (facial pain or headache) each of at least moderate intensity (score =2) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 437 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 77
Exclusion criteria
Exclusion criteria: 1. Sinus surgery within the last 2 years (solitary sinus puncture is allowed) 2. Inferior turbinate reduction (by surgery or other methods) within the last 3 months 3. Presence or history of uni- or bilateral nasal polyps 4. Moderate to severe co-morbid asthma, including allergic asthma 5. Cystic fibrosis 6. Perennial (e.g. patients with clinical symptoms of allergic rhinitis against house dust/mite antigen) or seasonal allergic rhinitis 7. Rhinitis medicamentosa (drug induced rhinitis) 8. Aspirin-exacerbated respiratory disease (aspirin sensitivity) 9. Dentogenic sinusitis or otherwise unilateral sinusitis 10. Presence of anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation/airflow 11. Known hypersensitivity to trial medication or excipients 12. Rare hereditary problems of fructose intolerance, galactose intolerance, lactase deficiency, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency 13. Signs or symptoms of acute bacterial sinusitis (e.g. fever >38.5°C, orbital complications, severe unilateral frontal headache, or toothache) 14. Treatment with antihistamines within 4 weeks prior to V1 15. Treatment with 2-3.5% hypertonic saline solution within 2 weeks prior to V1 16. Treatment with systemic or nasal antibiotics or corticosteroids within 4 weeks prior to V1 17. Treatment with decongestant preparations (a-sympathomimetics), analgesics (including systemic non-steroidal inflammatory drugs [NSAIDs], including paracetamol), mucolytics/secretolytics, or alternative medicine preparations for treatment of common cold-like symptoms or with immunomodulating properties within 7 days prior to V1 18. Peptic ulcer 19. Gastritis 20. Other diseases within 5 years prior to V1 that, in the opinion of the investigator, disqualifies the patient for trial enrolment (e.g. liver or kidney disease, severe somatopathic, neurological and/or psychiatric diseases, history of malignancy, alcohol or drug abuse, or immunodeficiency) 21. Parallel participation in another clinical trial, participation in a different trial within less than 6 weeks prior to trial entry, or previous randomization into this clinical trial 22. Known to be, or suspected of being unable to comply with the clinical trial protocol (CTP) that in the opinion of the investigator disqualifies the patient for trial enrolment (e.g. no permanent address, known to be non-compliant, or presenting an unstable psychiatric history) 23. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope, and possible impact of the clinical trial 24. Patients in custody by juridical or official order 25. Patients who have difficulties in understanding the local language in which the patient information (PI) is given 26. Patients who are members of the staff of the investigational site, staff of the sponsor or involved CRO, the investigator him/herself or close relatives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of the herbal medicinal product Sinupret extract versus placebo in the treatment of chronic rhinosinusitis (CRS) in adults.;Secondary Objective: • To assess safety and tolerability of Sinupret extract versus placebo during the 16-week treatment phase and the 4-week follow-up phase. • To assess the effect of Sinupret extract versus placebo on selected inflammatory parameters in nasal secretions after 8- and 16-week treatment periods compared to baseline in a subset of approximately 60 patients.;Primary end point(s): The primary efficacy endpoint of this trial is MSSINV at V7.;Timepoint(s) of evaluation of this end point: Visit 7 (week 16). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. MSSINV at V4, V5, and V6 2. Major symptom score as assessed by the patient (MSSPAT) at V4, V5, V6, and V7 3. Minimal MSSINV of all visits from V4 to V7 4. Minimal MSSPAT of all visits from V4 to V7 5. Investigator’s ratings of each individual CRS symptom (i.e. rhinorrhea [anterior], rhinorrhea [posterior], nasal congestion, headache, and facial pain/pressure) at V4, V5, V6, and V7 6. Patient’s ratings of each individual CRS symptom (i.e. rhinorrhea [anterior], rhinorrhea [posterior], nasal congestion, headache, and facial pain/pressure) at V4, V5, V6, and V7 7. 22-Item Sino-Nasal Outcome Test total score (SNOT-22Total Score) as well as SNOT-22 primary nasal score (SNOT-22 PNS) and SNOT-22 general quality of life score (SNOT-22ALQ) at V4, V5, V6, and V7 8. Total symptom severity assessed by the patient on a visual analogue scale (VAS) at V4, V5, V6, and V7 9. Proportion of patients whose MSSINV and MSSPAT improved by =30%, =40%, =50%, =60% and =70% at V4, V5, V6, and V7. Responders are defined as patients who show at least an MSS improvement of =30% 10. Patients with permitted concomitant drug and non-drug therapy (i.e. isotonic saline solution as nasal spray, nasal irrigation [nasal lavage], or ultrasonic nebulizer) for CRS 11. Patients with premature termination due to exacerbation of CRS symptoms 12. Investigator’s and patient’s overall assessment of efficacy at V4, V5, V6, and V7 13. Absolute concentrations of selected inflammatory parameters (e.g. myeloperoxidase [MPO], eosinophil cationic protein [ECP], cytokines, a2-macroglobulin, HMGB-1, albumin) in nasal secretions collected at V2, V5 and V7 for a subset of approximately 60 patients in approximately 10 investigational sites in Germany 14. Change from baseline (V2) in the concentration of selected inflammatory parameters (e.g. MPO, ECP, cytokines, a2-macroglobulin, HMGB-1, albumin) in nasal secretions at V5 and V7 for a subset of approximately 60 patients in approximate | — |
Countries
Germany, Poland
Contacts
Public ContactClinical Research International Dep
Bionorica SE
Outcome results
None listed